BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EPIDURAL CATHETERIZATION SET

    MDR report key: 3915390 · Received May 28, 2014

    Report

    Report Number
    3006425876-2014-00114
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 2, 2014
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THERE IS A DEFECT IN THE SYRINGE/TUOHY NEEDLE CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314543 ARROW EPIDURAL CATHETERIZATION SET CAZ ARROW INTERNATIONAL INC 71F1481051

    Patients

    Seq Age Sex Outcome Treatment
    1